# K112150: Profemur Gladiator HA Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 23, 2011 after 119 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935452 (1994). 23 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100866: Profemur Hip System Modular Necks, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K091423: Profemur Hip System Modular Necks, Wrightmedicaltechnologyinc (2009) Summary page 1.
- K021346: Stem Hip Replacement System, Model PHA002XX, Wrightmedicaltechnologyinc (2002) Summary page 1.
- K012091: Pro-Femur, Wrightmedicaltechnologyinc (2001) Summary page 1.
- K060358: Profemur TL Hip Stem, Wrightmedicaltechnologyinc (2006) Summary page 1.
- K953111: Corail, Landos, Inc. (1996) Summary page 1.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K105995: CORAIL Hip Prosthesis. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K200007: PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar (2020), 1 descendant of its own
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling (2018), 1 descendant of its own
- K250444: NEXUS® Hip Stem (2025), 0 descendants of its own
- K240452: Ceramic Femoral Head (2024), 0 descendants of its own

## Indications for use
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Gladiator HA Hip Stem is intended for cementless hip arthroplasty.

Source page: https://510kreport.com/device/K112150
Methodology: https://510kreport.com/methodology